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NCT01386658 · ClinicalTrials.gov registry record · Phase 3
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 32
- Enrollment target
NCT01386658: Completed Phase 3 study, sponsored by Shire.
NCT01386658 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 32 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01386658, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 32 participants
- Enrollment target
Study Summary
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.
Primary Outcome
Time to peak concentration (Tmax) of a single SC dose of icatibant was reported.
Interventions
- DRUG icatibant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-01-27 |
| Est. Completion | 2018-03-12 |
| Phase | Phase 3 |
What the finished NCT01386658 record still lists
NCT01386658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which icatibant is the first listed.
NCT01386658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01386658 about?
NCT01386658 is a clinical study titled "A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema". HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) d...
What is the current status of trial NCT01386658?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 32 participants. The study started on 2012-01-27. Estimated completion is 2018-03-12.
What interventions are being tested in trial NCT01386658?
The interventions under investigation include: icatibant (DRUG).
Who is sponsoring clinical trial NCT01386658?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01386658's enrollment target sits among peer trials
32 1909th of 2000 higher than 87 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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